BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H, HA COATED STEM SIZE 3 STD

    MDR report key: 6263410 · Received January 19, 2017

    Report

    Report Number
    3005180920-2016-00748
    Event Type
    Injury
    Date Received
    January 19, 2017
    Date of Event
    December 20, 2016
    Report Date
    January 19, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 05 JANUARY 2017 THE MEDICAL AFFAIRS DIRECTOR PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: FEMORAL STEM MOBILIZATION IN A (B)(6) MAN FOUR YEARS AFTER SURGERY. THE STEM SHOWS AN EVIDENT RADIOLUCENCY INGRUEN ZONE 1 & 2, SIGNS OF PROXIMAL MOBILIZATION. THE CUP APPEARS TO BE RATHER PROMINENT, BUT THERE IS NO INDICATION THAT ANY IMPINGEMENT BETWEEN STEM AND CUP TOOK PLACE EVER. THE REASONS FOR THIS LOOSENING REMAIN UNKNOWN. ASEPTIC LOOSENING IS A POSSIBLE, LITERATURE-DESCRIBED ADVERSE EVENT FOLLOWING THA, AND THE CAUSES ARE OFTEN UNDETERMINED. BATCH REVIEW PERFORMED ON 16 JANUARY 2017. LOT 122926: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02 OCTOBER 2012. EXPIRATION DATE: 2017-08-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF INSTABILITY. THE PATIENT HAD ASEPTIC LOOSENING. THE SURGEON REVISED THE STEM, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS ARE AVAILABLE. EXPLANTS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47069 AMISTEM H, HA COATED STEM SIZE 3 STD CEMENTLESS FEMORAL STEM LZO MEDACTA INTERNATIONAL SA 122926

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention